1、Designation: F366 10 (Reapproved 2015)Standard Specification forFixation Pins and Wires1This standard is issued under the fixed designation F366; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A number i
2、n parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers functional dimensions forfixation pins and wires.1.2 In recognition of many broad and varied uses of suchpins and wir
3、es, many options are included. A variety, but notnecessarily all, of the options are illustrated in Figs. 1-3.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for U
4、nalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF
5、90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium
6、14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F368 Specification for Fixation Pins-Knowles and HagieTypes (Withdrawn 1982)3F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specific
7、ation for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563) (With-drawn 2005)3F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implant
8、s(UNS S20910)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNSR31537, UNS R31538, and UNS R31539)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants (UNS S31675)3.
9、Materials3.1 Fixation pins and wires shall be fabricated from materialconforming to one of the followingASTM Specifications: F67,F75, F90, F136, F138, F562, F563, F1314, F1537, and F1586.4. Performance Requirements4.1 Factors considered to be important, but for which valuesand test methods have not
10、been established, are bendingstrength, fatigue strength, breaking strength (Knowles Typeonly), torsion strength, and ductility.5. Dimensions and Characteristics5.1 Fixation pins and wires shall be fabricated in accordancewith the dimensions illustrated in Figs. 1-4.5.2 Fixation pins and wires shall
11、have surfaces prepared andmarked in accordance with Practice F86.5.2.1 Optional marking on the fixation pins and wires shallidentify the manufacturer or distributor.6. Packaging and Labeling6.1 Packaging shall be adequate to protect the fixation pinsand wires during shipment.6.2 Labeling for fixatio
12、n pins and wires shall include:6.2.1 Product name,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved March 1, 2015. Published April 2015. Or
13、iginallyapproved in 1973. Last previous edition approved in 2010 as F366 10. DOI:10.1520/F0366-10R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards D
14、ocument Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16.2.2 Size, on the immediate container,6.2.2.1 Length,6.2.2.2
15、Diameter (if round) or cross-sectional size (if squareof hexagonal), that is, 6.4 mm square, and6.2.3 ASTM material specification Designation number.7. Keywords7.1 fixation materials; flexible surgical wire; orthopaedicmedical devices; wire-surgical implantsNOTE 1Pins and wires may be smooth shank o
16、r threaded.NOTE 2Point angle and helix angle, where applicable, is as specified by manufacturer.NOTE 3On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins largerthan 3.2 mm may be reduced.NOTE 4Optional designs, both e
17、nds pointed or point with suture hole.FIG. 1 Fixation Pins and WiresF366 10 (2015)2NOTE 1Shall be made of one piece of material; that is, not an assembly of two or more pieces.NOTE 2Thread major diameter may be the same or larger than the shaft diameter.NOTE 3Thread length shall be optional to suit
18、intended medical application.NOTE 4Optional marking in this location.FIG. 2 Fixation Pin-Knowles TypeNOTE 1Thread major diameter may be the same or larger than the shaft diameter.NOTE 2Thread length shall be optional to suit intended medical application.FIG. 3 Fixation Pin-Hagie TypeF366 10 (2015)3A
19、PPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary reasons for the revision of this specifica-tion are:X1.1.1 To characterize fixation pins and wires used in thetreatment of fractures or disease of the skeletal system.X1.1.2 To incorporate fixation pinsKnowles and Hagietypes (Specificati
20、on F368).X1.1.3 To specify marking nomenclature.X1.1.4 To add performance requirements in accordancewith Performance Sections request.X1.1.5 To add packaging and labeling.X1.1.6 To remove the dimensions on the Crowe since thedimensions are not essential.X1.1.7 Specific surface finish was considered,
21、 however, notincluded, since test data to confirm what the requirementshould be or what effect it has upon performance was notavailable.X1.2 Designs listed enable the surgeon to select from avariety of fixation pins and wires.X1.3 The materials listed represent the current usage andhave demonstrated
22、 clinical acceptance in these devices.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the r
23、iskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of t
24、his standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmak
25、e your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained b
26、y contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 4 Nut for Hagie PinF366 10 (2015)4
